Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor

February 26, 2024 updated by: Eli Lilly and Company

Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment

Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor.

The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Diagnosis of cancer with RET mutant (medullary thyroid cancer [MTC] or multiple endocrine neoplasia type 2 [MEN2] tumors) or RET fusion (solid tumors) advanced/metastatic tumors that have become refractory to RET selective tyrosine kinase inhibitor (TKI) treatment, who are not eligible or able to participate in an ongoing LOXO-260 clinical trial and are medically suitable for treatment with LOXO-260.
  • Patients tumor must have developed RET solvent front mutations (eg G810X) after RET selective treatment.
  • Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
  • Have adequate organ function
  • Patients must reside in a country where the LOXO-NGR-21001 study (NCT05241834) is not open or recruiting.

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of LOXO-260 or another second generation RET inhibitor
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
  • Clinically significant malabsorption syndrome
  • Pregnant or lactating
  • Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4
  • Patients harboring known activating bypass alterations outside RET (eg. EGFR, ALK, RAS etc) that may confer resistance to LOXO-260

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Loxo Oncology, Inc.

Investigators

  • Study Director: Emin Avsar, MD, Loxo Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOXO-260 Expanded Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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